See ratings and reviews when you sign up for an account.

A Prospective Patient Registry for Bone Graft Substitutes in Spinal Fusion: Patient Outcomes and Use in Clinical Practice

This study is currently Recruiting

May 2011 By Apatech, Inc.

First Recieved on September 8, 2009

Last Updated on May 20, 2011

Sponsor: Apatech, Inc.
Information provided by: Apatech, Inc.
Identifier: NCT00974623


A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.

Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective


Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Inclusion Criteria: - The patient has failed conservative treatment and is a candidate for spinal fusion surgery. - The patient is ?18 years old and of legal age of consent. - The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. - The patient is skeletally mature (epiphyses closed). - The patient has signed the IRB approved informed consent. - The patient is willing and able to participate in post-operative clinical and radiographic follow up evaluations for 2 years. Exclusion Criteria: - Patient has systemic infection or infection at the surgical site. - Patient has a medical condition that would interfere with post-operative assessments and care (i.e., neuromuscular disease, psychiatric disease, paraplegia, quadriplegia, etc.). - Patient is in poor general health or any concurrent disease process that would place the patient in excessive risk to surgery (i.e., significant circulatory or pulmonary problems, or cardiac disease). - Patient has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the patient's ability to complete the protocol required follow-up. - The patient is pregnant/breastfeeding at the time of enrollment, or plans to become pregnant during the course of the study. - Patient is participating in another investigational study, which could confound results.


  • Investigator: Melanie Marshall - Study Director - VP of Clinical Operations


  • UCSF

    San Francisco, California 94143 United States

  • St. Joseph's Hospital - Resurgeons Orthopedics

    Atlanta, Georgia 30342 United States

  • Arthritis & Joint Center - U. Mass. Memorial

    Worcester, Massachusetts 01605 United States


    Southfield, Michigan 48072 United States

  • Montana Neuroscience Institute Foundation

    Missoula, Montana 59802 United States

  • Syracuse Orthopedic Specialists

    Syracuse, New York 13215 United States

  • Neurosurgical Associates

    Nashville, Tennessee 37203 United States

  • Brain & Spine of Texas

    Plano, Texas 75093 United States

Conditions related to this trial:

Disclaimer: The list and ratings above are for informational purposes only, and is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. The goal of the information is to provide you with a comprehensive view of all available treatments, but should not be construed to indicate that use of any one treatment is safe, appropriate, or effective for you. Decisions about use of a new treatment, or about a change in your current treatment plan, should be in consultation with your doctor or other healthcare professional.